RADIADYNE, L.L.C.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Prostate Immobilizer Rectal Balloon (PCT) (6) Dosimeter, Ionizing Radiation, Implanted (NZT) (4) Accelerator, Linear, Medical (IYE) (1) System, Applicator, Radionuclide, Remote-Controlled (JAQ) (1)

Premarket Exempt

Clear

Alatus - 00851546007004 Catalog Number : ALA-45

Device Description : Alatus Vaginal Balloon Packing System Kit

Device Class :

Duns Number: 005744772

Premarket Exempt : No

Product Code : IYE, JAQ

Prescription Use : Yes

Device Count : 1

ImmobiLoc - 00851546007011 Catalog Number : IL-60

Device Description : ImmobiLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit

Device Class : 2

Duns Number: 005744772

Premarket Exempt : No

Product Code : PCT

Prescription Use : Yes

Device Count : 1

ImmobiLoc - 00851546007028 Catalog Number : IL-100

Device Description : ImmobiLoc Prostate Immobilization Treatment Balloon Device Kit

Device Class : 2

Duns Number: 005744772

Premarket Exempt : No

Product Code : PCT

Prescription Use : Yes

Device Count : 1

ImmobiLoc - 00851546007035 Catalog Number : ILG-60F

Device Description : ImmobiLoc Gas Release Short Profile Prostate Immobilization Treatment Balloon Device Kit

Device Class : 2

Duns Number: 005744772

Premarket Exempt : No

Product Code : PCT

Prescription Use : Yes

Device Count : 1

ImmobiLoc - 00851546007042 Catalog Number : ILG-60F060ml

Device Description : ImmobiLoc Gas Release Short Profile Prostate Immobilization Treatment Balloon De ImmobiLoc Gas Release Short Profile Prostate Immobilization Treatment Balloon Device Kit W/60ml syringe

Device Class : 2

Duns Number: 005744772

Premarket Exempt : No

Product Code : PCT

Prescription Use : Yes

Device Count : 1

ImmobiLoc - 00851546007059 Catalog Number : ILG-90F

Device Description : ImmobiLoc Gas Release Prostate Immobilization Treatment Balloon Device Kit

Device Class : 2

Duns Number: 005744772

Premarket Exempt : No

Product Code : PCT

Prescription Use : Yes

Device Count : 1

OARtrac - 00851546007066 Catalog Number : ORB-60F

Device Description : OARtrac Disposable Gas Release Short Profile Prostate Immobilization Treatment B OARtrac Disposable Gas Release Short Profile Prostate Immobilization Treatment Balloon Device Kit, with Fiducial Marker and PSD Sensor Bundle

Device Class : 2

Duns Number: 005744772

Premarket Exempt : No

Product Code : NZT, PCT

Prescription Use : Yes

Device Count : 1

OARtrac - 00851546007073 Catalog Number : OT1-PSD-2U

Device Description : OARtrac Plastic Scintillating Detector - Duplex Disposable Skin Sensor Cable

Device Class : 2

Duns Number: 005744772

Premarket Exempt : No

Product Code : NZT

Prescription Use : Yes

Device Count : 1

OARtrac - 00851546007080 Catalog Number : OT-CDU

Device Description : OARtrac Clinical Detector Unit (CDU) with its Charged Coupled Device (CCD) camer OARtrac Clinical Detector Unit (CDU) with its Charged Coupled Device (CCD) camera and the system’s own proprietary dose management software.

Device Class : 2

Duns Number: 005744772

Premarket Exempt : No

Product Code : NZT

Prescription Use : No

Device Count : 1

OARtrac - 00851546007097 Catalog Number : OT-PSS

Device Description : OARtrac Proprietary System Software for CDU

Device Class : 2

Duns Number: 005744772

Premarket Exempt : No

Product Code : NZT

Prescription Use : No

Device Count : 1

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